Research Center

Join the Research Team!

We often hear the phrase "meet the team" before the start of a sports season. Here, we invite you to meet the research team. Research involves a lot of people who have different roles; much like a sports team has different coaches, players, referees and fans. Both on a sports team and in research each person plays a vital role and like a game, research can only be done with the all team members.

Head CoachLet's start with the head coach. The Principal Investigator (PI) is like the head coach because he or she is an expert in the topic. They are most responsible for planning the research study and the work of the rest of the team. The head coach, researcher/PI has to follow a playbook. This playbook is called a "protocol". A protocol is a guide researchers must follow during the research study. Like sports, the guide must be in line with the rules of the game. The research study can only begin after the "protocol" has been reviewed by the IRB. The IRB tells the researcher/PI the rules that must be used before the study starts. Following the rules helps keep the volunteer safe during the study.

Assistant Coaches
The research staff is like the assistant coaches. Why? Because the research staff handles most of the day-to-day activities and works closely with the head coach. The research staff is there for you when you or your family and friends have questions about the research study. You can call them if you have any questions or concerns about the study! Just as coaches and assistant coaches must complete special training before they are allowed to coach a game, the PI and research staff must also complete special training to ensure that they understand the rules of research.

Volunteers
Research volunteers are the MOST important members on the research team. Like a game can only be played with players, research can only be done with volunteers. Research studies need all kinds of people to volunteer. (In the same way that you don't have a team without the players, researchers cannot learn about what works and what doesn't without volunteers). For example, for a long time heart disease was thought to be a man's disease and was only studied in men. Because women were not studied, little was known about the symptoms of heart attacks in women or what treatments were effective. Now we know women get heart disease, too, and their symptoms are often different from those that men have.

Research studies need volunteers of all ages, genders, races, and ethnicities. Volunteers can be tall or short, rich or poor, and thin or heavy. They are not always people with an illness. Healthy people can also volunteer to take part in research.

Volunteers from each of these groups are important for different reasons. For example, children volunteers are needed to learn more about childhood diseases such as childhood asthma. Elderly volunteers help researchers learn about concerns and conditions that effect only older people. Volunteers of different races and ethnicities are important to learn more about diseases that are more common among them and because some treatments work differently for different groups of people. For example, type-2 diabetes and asthma are more common in African Americans and Hispanics.

This is why it is so important that people of all ages, genders, races and ethnic groups take part in research studies. It is the only way that researchers can find treatments for all people and that researchers can know the different ways different people respond to different treatments.

Family, friends and personal support
Much like a sports team has fans to observe the game and cheer the team to victory, your family, friends and personal support are people you can talk with about taking part in the study. You may share with them what the study is about. They may have questions about the study. They may also help support you during the study. The final decision though, is yours, as to whether you will take part or not.

Referees
Like a sports team, the referees are the people that protect your safety. In research, there are national rule makers or regulators, the Food and Drug Administration (FDA); local, Institutional Review Board (IRB); and institutional, research subject advocates (RSAs). The research rule makers:

review the research study before it starts

make sure all rules are being followed, and

help keep you safe and informed.

Referees help teams follow certain rules. In sports these rules protect the safety of the players and depend on the game. In research, rules also protect the safety of volunteers and are different depending on the type of research.

At the national level, the Food and Drug Administration (FDA) has an official guide or set of rules that all researchers must follow. These rules are also called the "Common Rules." This means that these rules apply to or are "common" to all studies that involve humans.

Locally, IRBs help researchers follow those rules. IRB is a complex term. The B stands of BOARD. This means that it is a group of people that looks at the research study. R is for REVIEW, meaning that the study is checked closely to see that rules are followed. The I stands for INSTITUTIONAL, meaning that the study follows rules that apply to wherever the research will be done. Research goes on at hospitals, colleges, and other places, and the IRB is the local group that helps to keep volunteers safe by overseeing study activities at these locations.

There are other local referees whose job is to support volunteers more directly. These people are often called "participant advocates" or sometimes "research subject advocates." They are the insiders who can help you while you are in the study. They are there to support you. You can contact them at any time. If you have questions or need help with some aspect of your taking part.

Helpful Research Terms

Clinical research: a type of research that involves a particular person or group of people

Clinical trial: a particular type of clinical research that tests whether a new medicine or device is safe and effective

Consent form: One part of the informed consent process (see “informed consent”). A consent form is a document that describes and explains the parts of the study. Each form has at least 8 parts. The parts will cover what the study is about, who can join, what you will be asked to do, any risks or benefits, any costs, any inconvenience, what your information will be used for, and that your taking part is voluntary. After all questions have been answered and the volunteer agrees, it is signed by the volunteer. By choosing to sign the consent form, a person shows that s/he understands the study and is willing to take part.

Purpose: why the research is being done

Procedures: what the study involves, including how long the study will take

Risks: what could happen if you join a study

Benefits: what you might get out of joining

Alternatives: what your other options are

Confidentiality: data you provide is not shared with anyone that you have not agreed can see it

Cost or compensation: any money you might have to pay or you might be paid

Questions: names and numbers of the people you can call if you have questions or problems

Voluntary: it’s up to you – it’s your choice

Data: the information that researchers get and look at

Device: A piece of equipment made for a particular purpose; especially a mechanical or electrical one. An example would be a pacemaker.

Eligibility: A process of finding out whether a volunteer is a good fit or match for a study.

FDA (Food and Drug Administration): A government agency that monitors and approves drugs and devices before they can be used in the general public; one of the “referees.”

Informed consent: A process that involves talking with a study team about why they’re doing the study, what you will have to do while taking part in a research study, how much time it will take, whether you will be paid , whom to contact if you have questions – everything you need to know about volunteering. Part of the informed consent process includes a consent form (see “consent form”).

Investigator: A professional, usually a doctor, but may also be a nurse, pharmacist or other health care professional; one of the “coaches.”

IRB (Institutional Review Board): A special group of professionals who look over research studies to protect the safety of study participants; one of the “referees.”

Observations: Looking at and learning why things are the way they are.

Participant: A person taking part in a study. Also called a research volunteer or research subject; one of the “players.”

Protocol: The study plan; the “play book.”

Recruitment: Finding and getting people to join a study.

Research Subject: A person taking part in a study. Also called a participant or research volunteer; one of the “players.”

Research Volunteer: A person taking part in a study. Also called a participant or research subject; one of the “players.”

Retention: Refers to the completion of follow-up visits and procedures involved in the study; staying in the study until it is completed.

Sample: A small set of a larger group.

Standard Treatment: The treatment we know works for most people and that usually happens at the doctor’s office or hospital; part of usual care (see “usual care”).

Surveys: The use of written or verbal questions to gather information about people’s thoughts and behaviors.

Usual Care: What you normally get at the doctor’s office; includes preventative health care, routine screenings, and standard treatment (see “standard treatment”).

Please note: only your personal physician or other health professional you consult can best advise you on matters of your health based on your medical history, your family medical history, your medication history, and how information from any of these databases may apply to you. Neither University of Cincinnati (NetWellness) nor any party involved in creating, producing or delivering this web site shall be liable for any damages arising out of access to or use of this web site, or any errors or omissions in the content thereof. (More)